Antios Therapeutics received a clinical hold on its Hepatitis B virus (HBV) combinatorial therapy from the U.S. Food and Drug Administration on Wednesday.
Tyvaso DPI marks the first approval of a dry powder inhaler for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Several biopharma companies are opening the week with positive clinical trial news. Read on for updates from Cytokinetics, Concert Pharmaceuticals, Idorsia and Seagen.
Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Celebrities’ struggles with breast cancer are bringing new awareness to the importance of screening - particularly because new therapies like Radius Health’s elacestrant are on the horizon.
On Thursday, Mersana announced that the FDA granted an orphan drug designation to one of its lead assets, XMT-2056, which is intended to treat gastric cancer.
On Wednesday evening, a man in Massachusetts became the first person reported to have a case of monkeypox in the U.S. The man contracted monkeypox after traveling to Canada.
GeNeuro is developing therapeutics that tackle the viral proteins that potentially contribute to neurodegeneration seen in patients with MS, amyotrophic lateral sclerosis (ALS) and even COVID-19.
Applied Molecular Transport (AMT) provided a strategy update on Wednesday. Part of the update includes reducing its workforce by about 40% and funneling resources into its lead program.
Axsome Therapeutics announced that it published the results of its Ascend Phase-II clinical trial of AXS-05 to treat Major Depressive Disorder in The American Journal of Psychiatry.
Avrobio presented clinical data on Tuesday at the 25th Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT) from its trial of AVR-RD-04, and preliminary results are promising.
Moderna held its first in-person Science and Technology Day since 2019. Notably, the company shared information about its new inhalable lipid nanoparticles (LNPs).